[Federal Register Volume 73, Number 159 (Friday, August 15, 2008)]
[Rules and Regulations]
[Pages 47828-47829]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-18863]
[[Page 47828]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. FDA-2008-P-0090] (formerly Docket No. 2006P-0393)
Food Labeling: Health Claims; Soluble Fiber From Certain Foods
and Risk of Coronary Heart Disease
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is adopting as a final
rule, without change, the provisions of the interim final rule (IFR)
that amended the regulation authorizing a health claim on soluble fiber
from certain foods and risk of coronary heart disease (CHD), to add
barley betafiber as an additional eligible source of beta-glucan
soluble fiber. FDA is taking this action to complete the rulemaking
initiated with the IFR.
DATES: This final rule is effective August 15, 2008.
FOR FURTHER INFORMATION CONTACT: Jillonne Kevala, Center for Food
Safety and Applied Nutrition (HFS-830), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1450.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of February 25, 2008 (73 FR 9938), FDA
published an IFR to amend the regulation in part 101 (21 CFR part 101)
that authorizes a health claim on the relationship between soluble
fiber from certain foods and CHD (Sec. 101.81), to include barley
betafiber as an additional eligible source of beta-glucan soluble
fiber. Under section 403(r)(3)(B)(i) and (r)(7) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 343(r)(3)(B)(i) and
343(r)(7)), FDA issued the IFR in response to a petition filed under
section 403(r)(4) of the act. On June 20, 2006, Cargill Inc. (the
petitioner), submitted a health claim petition to FDA requesting that
the agency expand the ``Soluble fiber from certain foods and coronary
heart disease'' health claim (Sec. 101.81) to include barley betafiber
as an eligible food ingredient source of beta-glucan soluble fiber. The
petitioner requested that FDA grant an IFR by which foods containing
barley betafiber could bear the health claim prior to publication of
the final rule.
Section 403(r)(3)(B)(i) of the act states that the Secretary of
Health and Human Services (and, by delegation, FDA) shall issue a
regulation authorizing a health claim if he or she ``determines, based
on the totality of publicly available scientific evidence (including
evidence from well-designed studies conducted in a manner which is
consistent with generally recognized scientific procedures and
principles), that there is significant scientific agreement, among
experts qualified by scientific training and experience to evaluate
such claims, that the claim is supported by such evidence.'' (See also
Sec. 101.14(c).) Section 403(r)(4) of the act sets out the procedures
that FDA is to follow upon receiving a health claim petition. Section
403(r)(7) of the act permits FDA to make a proposed regulation issued
under section 403(r) effective upon publication pending consideration
of public comment and publication of a final regulation if the agency
determines that such action is necessary for public health reasons. FDA
filed the petition for comprehensive review in accordance with section
403(r)(4) of the act on September 28, 2006.
As part of its review of the scientific literature on barley
betafiber and CHD, FDA considered the scientific evidence presented in
the petition as well as information previously considered by the agency
on CHD risk reduction and the effects of beta-glucan soluble fiber
containing food ingredients on lowering serum total and low density
lipoprotein (LDL) cholesterol. The agency summarized this evidence in
the IFR (73 FR 9938 at 9941 to 9943). Based on the available evidence,
FDA concluded that barley betafiber, like the other whole oat and
barley products listed in Sec. 101.81(c)(2)(ii)(A), lowers serum total
and LDL cholesterol. Consequently, FDA amended Sec.
101.81(c)(2)(ii)(A) to broaden the health claim to include barley
betafiber as an additional eligible source of beta-glucan soluble
fiber.
II. Summary of Comments and the Agency's Response
FDA solicited comments on the IFR. The comment period closed on May
12, 2008. The agency received five letters of response, three from
consumers, one from academia, and one from the Commonwealth of
Kentucky. One consumer comment and the comment from academia supported
the IFR. The Commonwealth of Kentucky advised the agency that FDA's
ruling on the health claim would not adversely affect the State's
actions or conflict with any State laws. The remaining consumer
comments addressed issues that are outside the scope of this rulemaking
and will not be addressed here.
Given the absence of contrary evidence on the agency's decisions
announced in the IFR, FDA is adopting as a final rule, without change,
the IFR that amended Sec. 101.81 to include barley betafiber as an
additional eligible source of beta-glucan soluble fiber.
III. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this final rule is not a significant regulatory action under the
Executive order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this final rule allows new voluntary
behavior and imposes no additional restrictions on current practices,
the agency certifies that the final rule will not have a significant
economic impact on a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement which includes an assessment
of anticipated costs and benefits before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $127,000,000, using the most current (2006) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any one-year expenditure that would meet or
exceed this amount.
FDA received no comments relevant to economic impact. The costs and
benefits of available regulatory alternatives analyzed in the IFR (73
FR 9938 at 9944 and 9945) are adopted, without change, in this final
rule. By now affirming that IFR, FDA has not imposed any new
requirements. Therefore, there are no additional costs and benefits
associated with this final rule.
[[Page 47829]]
IV. Environmental Impact
The agency has determined under 21 CFR 25.32(p) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
V. Paperwork Reduction Act
FDA concludes that the labeling provisions of this final rule are
not subject to review by the Office of Management and Budget because
they do not constitute a ``collection of information'' under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Rather, the food
labeling health claim on the association between consumption of barley
betafiber and reduced risk of coronary heart disease is a ``public
disclosure of information originally supplied by the Federal Government
to the recipient for the purpose of disclosure to the public'' (5 CFR
1320.3(c)(2)).
VI. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
will have a preemptive effect on State law. Section 4(a) of the
Executive order requires agencies to ``construe * * * a Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress intended preemption of State law, or where the exercise of
State authority conflicts with the exercise of Federal authority under
the Federal statute.'' Section 403A of the act (21 U.S.C. 343-1) is an
express preemption provision. Section 403A(a)(5) of the act provides
that ``* * * no State or political subdivision of a State may directly
or indirectly establish under any authority or continue in effect as to
any food in interstate commerce--* * * any requirement respecting any
claim of the type described in section 403(r)(1) made in the label or
labeling of food that is not identical to the requirement of section
403(r). * * *''
On February 25, 2008, FDA published an IFR which imposed
requirements under section 403(r) of the act. This final rule affirms
the February 25, 2008, amendment to the existing food labeling
regulations to add barley betafiber to the authorized health claim for
soluble fiber from certain foods and CHD. Although this rule has a
preemptive effect in that it precludes States from issuing any health
claim labeling requirements for barley betafiber and reduced risk of
CHD that are not identical to those required by this final rule, this
preemptive effect is consistent with what Congress set forth in section
403A of the act. Section 403A(a)(5) of the act displaces both State
legislative requirements and State common law duties (Riegel v.
Medtronic, 128 S. Ct. 999 (2008)).
FDA believes that the preemptive effect of this final rule is
consistent with Executive Order 13132. Section 4(e) of the Executive
order provides that ``when an agency proposes to act through
adjudication or rulemaking to preempt State law, the agency shall
provide all affected State and local officials notice and an
opportunity for appropriate participation in the proceedings.'' On
December 12, 2007, FDA's Division of Federal and State Relations
provided notice via fax and e-mail transmission to State health
commissioners, State agriculture commissioners, food program directors,
and drug program directors, as well as FDA field personnel, of FDA's
intent to amend the health claim regulation authorizing health claims
for soluble fiber from certain foods and CHD (Sec. 101.81).
In addition, the agency sought input from all stakeholders through
publication of the IFR in the Federal Register on February 25, 2008.
FDA received one comment from the Commonwealth of Kentucky, which noted
that FDA's ruling on the health claim would not adversely affect the
State's actions or conflict with any State laws.
In conclusion, the agency believes that it has complied with all of
the applicable requirements of Executive Order 13132 and has determined
that the preemptive effects of this rule are consistent with the
Executive order.
List of Subjects in 21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
101 is amended as follows:
PART 101--FOOD LABELING
0
Accordingly, the interim final rule amending Sec. 101.81 that was
published in the Federal Register of February 25, 2008 (73 FR 9938), is
adopted as a final rule, without change.
Dated: August 7, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-18863 Filed 8-14-08; 8:45 am]
BILLING CODE 4160-01-S